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Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer

NCT ID: NCT00199485

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-06-30

Brief Summary

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Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.

Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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prostate cancer Luteinizing Hormone Releasing Hormone LHRH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Angelica Sinensis

Group Type EXPERIMENTAL

Angelica Sinensis

Intervention Type DRUG

Angelica Sinensis / placebo

2

placebo

Group Type PLACEBO_COMPARATOR

Angelica Sinensis

Intervention Type DRUG

Angelica Sinensis / placebo

Interventions

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Angelica Sinensis

Angelica Sinensis / placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Prostate cancer treated with some form of androgen deprivation therapy for at least one month. This includes either surgical (bilateral orchidectomy) or medical (LHRH agonist, pure or steroidal antiandrogen or combined) castration;
* Greater than seven vasomotor episodes per week;
* Significantly bothersome symptoms associated with these vasomotor episodes, which produce a desire in the patient to seek treatment to reduce both their incidence and severity;
* Documented informed consent to participate in the trial.

Exclusion Criteria

* Enrolment in any other clinical trial or study protocol;
* Presence of pain due to prostate cancer;
* Life expectancy less than three months;
* Any severe concomitant condition that would make it undesirable, in the clinician's opinion, or the subject to participate in the trial or would jeopardize compliance with the trial protocol;
* Concomitant anticoagulation therapy or history of bleeding disorder or blood dyscrasia;
* Known hypersensitivity to Dong Quai.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Health Care London

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Hassan Razvi, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Urology, St. Joseph's Hospital, University of Western Ontario

Locations

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Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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08217

Identifier Type: -

Identifier Source: secondary_id

S-01-007

Identifier Type: -

Identifier Source: org_study_id